This invention relates generally to voice prostheses and implantation procedures, and more specifically to a Method of Placing An Esophageal Voice Prosthesis In A Laryngectomized Person, to be performed by a surgeon on a patient who has undergone a laryngectomy (removal of the voice box) due to cancer or other conditions.
Advanced laryngeal carcinoma and its treatment have devastating effects on speech, swallowing, and respiration, and pose numerous challenges to a clinician. The impact of speech loss (aphonia) on the quality of life has few equals among medical handicaps. Speech provides an individual's presentation to society as well as his or her self-perception. Aphonia not only disrupts commerce with others but also changes relationships and dependencies, which may produce serious psychological stress and behavioral alterations. An individual's failure to adjust to this problem frequently results in permanent disability and withdrawal from society, sometimes leading to suicide.
Voice preservation has been an inseparable concern from the effective therapy of laryngeal cancer, as seen in the evolution of treatment over nearly 100 years. Rehabilitation of the voice may consist of an artificial larynx, acquisition of an esophageal voice, or a second operative procedure to restore continuity of the airway and alimentary tract. In addition, surgeons have developed neoglottic reconstructive procedures for total or near-total laryngectomy to diminish delays in secondary voice rehabilitation. A historical review of such treatments and devices may be found in Vocal Rehabilitation With Prosthetic Devices, Surgery For Cancer Of The Larynx, Drs. M. Singer, E. Blom.
A vocal rehabilitative method must be capable of solving a number of critical problems. Rehabilitation must not limit adequate cancer treatment in terms of the extent of surgical resection or tolerance to conventional-dose radiation therapy. Resulting deglutition should be normal and rapidly reacquired postoperatively. Patients should be free of dependence on complicated valves, tubes, and external devices; frequent endoscopy, dilatations, and revisions should not be required, oftentimes required by the prior art methods and devices. Prior art devices and methods have therefore suffered numerous drawbacks.
For example, the technique of developing esophageal speech patterns requires that the patient's main tracheal airway be connected to the central lower portion of the neck (tracheostoma). Swallowing occurs in the normal fashion through the hole in the neck after a laryngectomy. Esophageal speech is a technique which the patent can master without additional surgery or mechanical devices and is equivalent to a "belch." The patient belches air from the stomach into the posterior wall of the upper esophagus to create vibratory sounds in the back of the throat mimicking speech. This technique however suffers from the drawback that the patient can say only one or two words with each belch.
Devices such as the battery-powered electro-larynx devices available from Bell Laboratories have been frequently used to assist a patient in producing speech. This hand-held device is held against the side of the neck as the patient mimics words with his mouth, so that the device generates comprehensible vibratory sounds. This device does not require any surgery for use, however, many patients cannot master the technique to produce speech and others are extremely unhappy with the quality of the sound produced.
The VoiceBak artificial larynx developed by Dr. Taub in 1972, utilized an external shunt and required construction of a secondary esophagostoma in the lower lateral neck. This external device was inserted by attaching it at the esophagostoma, using a trumpet-shaped silicone connector, and tightening it against the skin with an adjustable tension collar. Tubing then traveled to a one-way saliva valve and to a regulator valve worn on the upper chest. This valve mechanism allowed two-way airflows for normal respiratory exchange. This device suffered from numerous drawbacks, including difficulty installing and maintaining the relatively large external device and the requirement of an additional esophagostoma.
Another prior method of voice restoration is commonly known as the trachea esophageal puncture method. Devices utilizing this method route air from the lungs directly into the esophagus through a tracheal esophageal puncture which is a hole made directly in the tracheostoma into the esophagus which lies directly behind it. A device such as a one-way valve is then inserted to vent air forced up through the trachea and directly into the esophagus. This permits a greater volume of air to enter the esophagus and create a vibratory sense similar to the sound developed with a belch. However, due to the increased volume, the patient may speak for a longer period of time and with more audible speech. One such device is that developed by Drs. Blom and Singer, known as the BLOM-SINGER Low Pressure Voice Prosthesis, covered by U.S. Pat. No. 4,614,516, manufactured and distributed by the American V. Mueller Co., a division of Travenol Labs, Inc., Anasco, Puerto Rico 00610.
The current method for the placement of this device requires that the patient be under general anesthesia. A rigid endoscope is introduced through the mouth and into the esophagus to aid the physician in puncturing the tracheostoma from outside. A rubber catheter is introduced through the tracheoesophageal fistula and must remain in place for 72 hours to permit the wound to heal before the duck-bill prosthesis is placed into the fistula. This prosthesis is a one-way valve which allows air to be vented directly from the trachea and into the esophagus.
The current method of placing this device in the operative position however, suffer from numerous drawbacks and complications. For example, the patient must undergo general anesthesia and suffer the inherent life-threatening risks associated therewith. Additionally, the rigid endoscope often traumatizes the esophagus and may cause a leak into the chest cavity (mediastinitis), which results in discomfort to the patient and a prolonged recovery period.
The method of the present invention overcomes the disadvantages of the prior art by providing a simple, safe and easily accomplished technique to place in a patient an esophageal voice prosthesis, which will benefit a large number of laryngectomees, without subjecting the patient to general anesthesia or requiring a lengthy hospital stay.